Label: ABUTOL SANITIZING ALOE VERA- benzalkonium chloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 5, 2020

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    • Hand sanitizer to decrease bacteria on the skin
    • Recommended for repeated use
    • For use when soap and water are not available

  • Warnings

    For external use only. Protect from the sunlight.

    Do not use
    • on children less than 2 months of age
    • on open skin wounds

    When using this product • Avoid use on/or around eyes, ears, mouth, broken/ irritated skin or large areas of body. In case of a contact with eyes, rinse thoroughly with water several minutes. do not inhale or ingest

    Stop out of reach of children
    If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    • Hold upright at 6-7 inches away from surface and spray evenly. Repeat application a necessary when using this product to avoid swallowing

  • Other information

    • store between 15-30 C (59-86F)

  • Inactive ingredients

    Aqua, FD&C Blue No.1, FD&C Red No.40, Glycerin, Parfum.

  • SPL UNCLASSIFIED SECTION

    Kills 99.99% of Germs *

    * KILLS 99.9 OF MOST COMMON GERMS, BACTERIA AND VIRUSES.

    Distributed by:
    American Brands and More LLC,
    Wood Ridge, NJ 07075

    Made in TURKEY
    You may also report any serious side effects to
    PO Box 328, Wood Ridge, NJ 07075-328

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ABUTOL SANITIZING ALOE VERA 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77418-803
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77418-803-101000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/06/2020
    Labeler - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI566218248manufacture(77418-803)
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